Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery

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dc.coverageDOI: 10.1186/s13063-021-05992-1
dc.creatorMarcucci, Maura
dc.creatorPainter, Thomas W.
dc.creatorConen, David
dc.creatorLeslie, Kate
dc.creatorLomivorotov, Vladimir V.
dc.creatorSessler, Daniel
dc.creatorChan, Matthew T.V.
dc.creatorBorges, Flavia K.
dc.creatorMartínez Zapata, Maria J.
dc.creatorWang, C. Y.
dc.creatorXavier, Denis
dc.creatorOfori, Sandra N.
dc.creatorLandoni, Giovanni
dc.creatorEfremov, Sergey
dc.creatorKleinlugtenbelt, Ydo V.
dc.creatorSzczeklik, Wojciech
dc.creatorSchmartz, Denis
dc.creatorGarg, Amit X.
dc.creatorShort, Timothy G.
dc.creatorWittmann, Maria
dc.creatorMeyhoff, Christian S.
dc.creatorAmir, Mohammed
dc.creatorTorres, David
dc.creatorPatel, Ameen
dc.creatorDuceppe, Emmanuelle
dc.creatorRuetzler, Kurtz
dc.creatorParlow, Joel L.
dc.creatorTandon, Vikas
dc.creatorWang, Michael K.
dc.creatorFleischmann, Edith
dc.creatorPolanczyk, Carisi A.
dc.creatorJayaram, Raja
dc.creatorAstrakov, Sergey V.
dc.creatorRao, Mangala
dc.creatorVanHelder, Tomas
dc.creatorWu, William K.K.
dc.creatorCheong, Chao Chia
dc.creatorAyad, Sabry
dc.creatorAbubakirov, Marat
dc.creatorKirov, Mikhail
dc.creatorBhatt, Keyur
dc.creatorde Nadal, Miriam
dc.creatorLikhvantsev, Valery
dc.creatorIglesisas, Pilar Paniagua
dc.creatorAguado, Hector J.
dc.creatorMcGillion, Michael
dc.creatorLamy, Andre
dc.creatorWhitlock, Richard P.
dc.creatorRoshanov, Pavel
dc.creatorStillo, David
dc.creatorCopland, Ingrid
dc.creatorVincent, Jessica
dc.creatorBalasubramanian, Kumar
dc.creatorBangdiwala, Shrikant I.
dc.creatorBiccard, Bruce
dc.creatorKurz, Andrea
dc.creatorSrinathan, Sadeesh
dc.creatorPetit, Shirley
dc.creatorEikelboom, John
dc.creatorRichards, Toby
dc.creatorGross, Peter L.
dc.creatorAlfonsi, Pascal
dc.creatorGuyatt, Gordon
dc.creatorBelley-Cote, Emily
dc.creatorSpence, Jessica
dc.creatorMcIntyre, William
dc.creatorYusuf, Salim
dc.creatorDevereaux, P. J.
dc.date2022
dc.date.accessioned2025-11-18T19:41:49Z
dc.date.available2025-11-18T19:41:49Z
dc.description<p>Background: For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. Although usual perioperative care is commonly consistent with a hypertension-avoidance strategy (i.e., most patients continue their antihypertensive medications throughout the perioperative period and intraoperative mean arterial pressures of 60 mmHg are commonly accepted), a hypotension-avoidance strategy may improve perioperative outcomes. Methods: The PeriOperative Ischemic Evaluation (POISE)-3 Trial is a large international randomized controlled trial designed to determine if TXA is superior to placebo for the composite outcome of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic events, at 30 days after randomization. Using a partial factorial design, POISE-3 will additionally determine the effect of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of major cardiovascular events, at 30 days after randomization. The target sample size is 10,000 participants. Patients ≥45 years of age undergoing noncardiac surgery, with or at risk of cardiovascular and bleeding complications, are randomized to receive a TXA 1 g intravenous bolus or matching placebo at the start and at the end of surgery. Patients, health care providers, data collectors, outcome adjudicators, and investigators are blinded to the treatment allocation. Patients on ≥ 1 chronic antihypertensive medication are also randomized to either of the two blood pressure management strategies, which differ in the management of patient antihypertensive medications on the morning of surgery and on the first 2 days after surgery, and in the target mean arterial pressure during surgery. Outcome adjudicators are blinded to the blood pressure treatment allocation. Patients are followed up at 30 days and 1 year after randomization. Discussion: Bleeding and hypotension in noncardiac surgery are common and have a substantial impact on patient prognosis. The POISE-3 trial will evaluate two interventions to determine their impact on bleeding, cardiovascular complications, and mortality. Trial registration: ClinicalTrials.gov NCT03505723. Registered on 23 April 2018.</p>eng
dc.identifierhttps://investigadores.uandes.cl/en/publications/ee589578-4303-473e-8161-54b8c93ea13e
dc.identifier.urihttps://repositorio.uandes.cl/handle/uandes/52012
dc.languageeng
dc.rightsinfo:eu-repo/semantics/openAccess
dc.sourcevol.23 (2022) nr.1
dc.subjectCardiovascular complications
dc.subjectNoncardiac surgery
dc.subjectPerioperative bleeding
dc.subjectPerioperative hypotension
dc.subjectRandomized controlled trial
dc.subjectTranexamic acid
dc.subjectPerioperative Care
dc.subjectTranexamic Acid/adverse effects
dc.subjectAntifibrinolytic Agents/adverse effects
dc.subjectHumans
dc.subjectHypotension/chemically induced
dc.subjectBlood Loss, Surgical/prevention & control
dc.titleRationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgeryeng
dc.typeArticleeng
dc.typeArtículospa
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